[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Notices]
[Pages 37058-37062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18062]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 797]
FY 1997; Studies To Evaluate the Epidemiologic and Laboratory
Characteristics of Human Immunodeficiency Virus (HIV) Infection Among
United States Blood and Plasma Donors
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1997 funds for cooperative agreements
to provide assistance for epidemiologic surveillance studies of human
immunodeficiency virus (HIV) in U.S. blood and plasma donors. These
studies will be conducted to describe the epidemiology of human
immunodeficiency virus (HIV), other retroviruses, and related
conditions in persons whose blood tests positive for HIV antibody, HIV
antigen, or other related laboratory markers. Additional funds will be
available for laboratory studies of the genetic variation of HIV among
blood and plasma donors and other selected populations.
CDC is committed to achieving the health promotion and disease
prevention objectives of ``Healthy People 2000,'' a national activity
to reduce morbidity and mortality and improve the quality of life. This
announcement is related to the priority area of HIV Infection. (For
ordering a copy of ``Healthy People 2000,'' see the Section WHERE TO
OBTAIN ADDITIONAL INFORMATION.)
Authority
This program is authorized under Sections 301(a) and 317(k)(2) of
the Public Health Service Act (42 U.S.C. 241(a) and 247b(k)(2)), as
amended. Applicable program regulations are set forth in 42 CFR Part
52, entitled ``Grants for Research Projects.''
Smoke-Free Workplace
CDC strongly encourages all cooperative agreement recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products. Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities that receive Federal funds in which
education, library, day care, health care, and early childhood
development services are provided to children.
Eligible Applicants
Eligible applicants include all nonprofit and for-profit blood
centers and organizations and governments and their agencies. Thus,
universities, colleges, research institutions, hospitals, and other
public and private organizations, State and local health departments or
their bona fide agents or instrumentalities, federally recognized
Indian tribal governments, Indian tribes or Indian tribal
organizations, and small, minority- or women-owned businesses are
eligible to apply.
Note: Organizations described in section 501(c)(4) of the
Internal Revenue Code of 1986 that engage in lobbying are not
eligible to receive Federal grant/cooperative agreement funds.
Availability of Funds
Approximately $1,200,000 will be available in FY 1997 to fund
approximately 5-10 awards. It is expected that the average award will
be approximately $200,000, with a range from $20,000 to $800,000. It is
expected that approximately 2 new and 6 competing renewal awards will
be made and that awards will begin on or about September 30, 1997.
Awards will be funded for a 12-month budget period within a project
period of up to 5 years. Funding estimates may vary and are subject to
change.
Continuation awards within the project period will be made on the
basis of satisfactory programmatic progress and the availability of
funds.
Use of Funds
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of Department
of Health and Human Services (HHS) funds for lobbying of Federal or
State legislative bodies. Under the provisions of 31 U.S.C. Section
1352 (which has been in effect since December 23, 1989), recipients
(and their subtier contractors) are prohibited from using appropriated
Federal funds (other than profits from a Federal contract) for lobbying
Congress or any Federal agency in connection with the award of a
particular contract, grant, cooperative agreement, or loan. This
includes grants/cooperative agreements that, in whole or in part,
involve conferences for which Federal funds cannot be used directly or
indirectly to encourage participants to lobby or to instruct
participants on how to lobby.
In addition, the FY 1997 Departments of Labor, HHS, and Education,
and Related Agencies Appropriations Act, which became effective October
1, 1996, expressly prohibits the use of 1997
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appropriated funds for indirect or ``grass roots'' lobbying efforts
that are designed to support or defeat legislation pending before State
legislatures. Section 503 of this new law, as enacted by the Omnibus
Consolidated Appropriations Act, 1997, Division A, Title I, Section
101(e), Public Law No. 104-208 (September 30, 1996), provides as
follows:
Sec. 503(a) No part of any appropriation contained in this Act
shall be used, other than for normal and recognized executive-
legislative relationships, for publicity or propaganda purposes, for
the preparation, distribution, or use of any kit, pamphlet, booklet,
publication, radio, television, or video presentation designed to
support or defeat legislation pending before the Congress, * * *
except in presentation to the Congress or any State legislative body
itself.
(b) No part of any appropriation contained in this Act shall be
used to pay the salary or expenses of any grant or contract
recipient, or agent acting for such recipient, related to any
activity designed to influence legislation or appropriations pending
before the Congress or any State legislature.
Background
In the United States, about 8 million people donate approximately
14 million units of whole blood each year; donors also give about 12
million units of plasma for use in making immune globulin, clotting
factors, and other products. During the last decade, improved donor
screening and education and better laboratory tests for blood-borne
viruses have markedly increased the safety of the nation's blood
supply.
The Centers for Disease Control and Prevention has monitored data
from the routine testing of blood donors since the first HIV antibody
screening test was licensed in 1985. Since 1988, CDC has collaborated
with the National American Red Cross and other major blood collection
agencies to systematically evaluate the characteristics of HIV-infected
donors through detailed interviews and follow-up. From 1988 to 1995,
the seroprevalence of HIV among blood donors decreased threefold, from
approximately 1 in 4,000 to 1 in 12,000 donors. This decrease was due
in part to the elimination of seropositive donors from the repeat donor
pool. However, HIV seroprevalence among first-time donors has also
declined. Because persons with known risks for HIV infection are
actively discouraged from donating, information about HIV-infected
donors identified during the screening process is valuable for further
improving donor deferral procedures and may offer clues to emerging
patterns of HIV transmission.
Current estimates of the residual risk of HIV transmission from
blood transfusion are based on mathematical models; these models
require estimates of the incidence of HIV infection among blood donors
and the length of the infectious window period. A recent analysis
suggested that there was a risk of 1 case of HIV transmission for every
450,000 to 660,000 donations of screened blood. This estimate is much
smaller than earlier estimates, principally because of the improved
sensitivity of enzyme immunoassay screening tests for HIV antibody. The
ability to monitor the risk of HIV transmission by blood transfusion
depends on methods for maintaining surveillance of incident HIV
infection among blood donors and characterizing the infectious window
period.
Since March 1996, donated blood has also been screened for HIV p24
antigen. On average, p24 antigen tests become positive approximately 6
days before enzyme immunoassays for HIV antibody. Surveillance
conducted by CDC, the National American Red Cross, and other blood
collection agencies suggest that p24 antigen screening has thus far
done little to improve blood safety; however, it has raised issues
concerning counseling and exclusion of donors who have false positive
test results and donors who may seek testing by a more sensitive test
than is routinely offered. In addition, concerns have been raised over
the presence of HIV strains poorly detected by commonly used screening
assays (e.g., group O). As testing technology continues to evolve,
blood donation provides a critical setting for evaluating the
performance characteristics of existing and new screening techniques,
as well as their potential impact on blood safety.
Although incidence and prevalence of HIV infection are lower among
blood donors than among unselected populations, the routine screening
of very large numbers of repeat blood donors identifies substantial
numbers of persons with recently acquired HIV infection. A newly
developed, ``detuned'' enzyme immunoassay can identify HIV infections
acquired during a relatively recent interval among first-time, as well
as repeat, donors and among other significant populations. Defining the
epidemiologic and laboratory characteristics of these recently infected
persons is important for understanding the evolution of the HIV
epidemic in the U.S. For example, HIV genomes from such persons are
needed for larger studies of subtype variation and primary drug
resistance.
Purpose
The purpose of these awards is to support research for
epidemiologic surveillance studies to gain a greater understanding of
the HIV epidemic and the safety of the U.S. blood supply. In
particular, studies with flexibility to support surveillance of other
transfusion-transmissible agents in addition to HIV will be considered.
I. Surveillance and Interview Studies of Blood and Plasma Donor
Populations
A. Monitor the prevalence and incidence of HIV infection in blood
and plasma donors at selected centers throughout the U.S. and Puerto
Rico.
B. Analyze the demographic, behavioral, and laboratory
characteristics of HIV-infected and non-infected donors to strengthen
the effectiveness of donor screening and deferral processes.
C. Estimate the risk of HIV transmission from screened blood and
plasma.
D. Identify persons and characteristics of persons recently
infected with HIV.
II. Laboratory Studies of Blood and Plasma Donors and Other Significant
Populations
A. Evaluate the effectiveness of screening blood donations for HIV-
1 p24 antigen.
B. Evaluate the performance of proposed or potential HIV screening
tests (e.g., amp-RT and viral RNA assays).
C. Describe the evolution of laboratory markers during the interval
between acquisition of HIV infection and seroconversion (including the
``window period'').
D. Conduct molecular epidemiologic studies of HIV and related
viruses in blood and plasma donors and other populations of
epidemiologic significance. These studies could include surveillance
for non-B HIV subtypes, primary antiretroviral drug resistance, and
segregation of viral strains according to demographic and behavioral
risk characteristics.
Applications should indicate whether they are addressing research
issues identified under sections I. or II. above, or both. Applications
for sections I. and II. will be evaluated separately.
Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient shall be responsible for the activities listed under A.
(Recipient Activities), and CDC shall be responsible for conducting
activities listed under B. (CDC Activities). The applications should be
presented in a manner that
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demonstrates the applicant's ability to address the proposed activities
in a collaborative manner with CDC.
A. Recipient Activities
1. Develop research study protocols, consent forms, questionnaires,
and data collection methods.
2. Identify, recruit, obtain informed consent from, and enroll an
adequate number of study participants as determined by study protocols
and program requirements.
3. Conduct epidemiologic studies at specified sites using approved
study protocols established through the recipient's participation with
CDC and other collaborating institutions.
4. Perform selected laboratory tests according to established
research protocols. Store all HIV seropositive sera and additional
specimens (sera or cells) as may be required by the research study
designs.
5. Participate in the development and maintenance of data
management systems for the study.
6. Share data and specimens with other collaborators when
appropriate to answer specific research questions.
7. Analyze study data and present findings in scientific
presentations and publications.
B. CDC Activities
1. Provide technical assistance in the design and conduct of the
research.
2. Provide technical guidance in the development of study
protocols, consent forms and questionnaires, including training and
pretesting as necessary.
3. Assist in designing a data management system. As requested,
carry out central data management functions.
4. As requested, perform selected laboratory tests.
5. Provide specimens for selected laboratory studies.
6. Facilitate collaboration among the different sites including
laboratories and consultants.
7. Collaborate with recipients in the analysis of research
information and the presentation of research findings.
Technical Reporting Requirements
1. An original and two copies of annual progress reports are
required no later than 90 days after the end of the budget period. The
annual reports for current awardees will be submitted with the renewal
application.
2. Final financial status and performance report is also required
no later than 90 days after the end of the project period. All reports
are submitted to the Grants Management Branch, Procurement and Grants
Office, CDC.
Application Content
Applications must be developed in accordance with PHS Form 5161-1
and the instructions outlined under the following section headings. The
application should provide a detailed description of first-year
activities and only briefly describe future-year activities. To assist
in evaluating the application, please limit the number of pages to 25
plus attachments.
A. Executive Summary
B. Table of Contents
C. Background and Needs
1. Demographic and geographic characteristics of the proposed study
population.
2. Reported cases of AIDS and/or HIV infection, patterns of
behavioral risk correlated illnesses (e.g., syphilis, hepatitis, etc.)
in the study population.
3. Previous efforts to conduct similar studies and uses of the
resulting data.
D. Capacity
1. Demonstrated knowledge, ability and resources to conduct
epidemiologic or laboratory studies.
2. Ability to enroll and evaluate adequate numbers of eligible
study participants or to obtain and examine appropriate numbers and
types of laboratory specimens.
3. Position descriptions for all key project personnel. These may
be included in the appendix but should be referenced in the text.
E. Goals and Objectives
1. List one or more goals for the project.
2. List specific measurable outcome objectives related to program
development and implementation; training and data quality; data
analysis and dissemination, including potential plans for linkage with
other data systems; and program evaluation.
F. Methods/Activities
1. Describe activities related to each objective.
2. Specify timelines for completing each activity.
3. Designate personnel resources and assignments to specific
project activities.
G. Project Evaluation
1. Evaluation plan should contain specific activities to collect
data to measure program development and implementation.
2. Describe how information will be obtained, prepared in specific
reports, and used to improve the program.
H. Budget
1. Line-item descriptive justification for personnel, travel,
supplies and other services should be submitted. Applicant should be
precise about the purpose of each budget item as it relates to the
project.
2. If applicable, applicants requesting funding for contracts
should include the name of the person or firm to receive the contract,
the method of selection, the period of performance, and a description
of the contracted service requested.
3. Funding levels for years two and through five should be
estimated.
I. Supporting Materials
1. Curriculum vitae and job descriptions of critical staff.
2. Letters of endorsement and/or collaboration of participating
centers, agencies and/or State or local public health departments.
Evaluation Criteria
Applications will be reviewed and evaluated according to the
following criteria:
1. The applicant demonstrates the knowledge, ability and resources
to conduct epidemiologic or laboratory studies of HIV and related
viruses in U.S. blood and plasma donors or other populations of
epidemiologic significance. (30 points)
2. The applicant demonstrates the ability to enroll and evaluate
adequate numbers of eligible study participants (e.g., HIV-seropositive
donors) or to obtain and examine appropriate numbers and types of
laboratory specimens. (25 points)
3. The applicant presents a sound plan for conducting and
evaluating program activities. If tests of clinical significance are
performed, the application should include a plan for notifying study
subjects. (15 points)
4. The applicant proposes objectives that are measurable, specific,
time-phased, and related to required recipient activities and program
purpose. (10 points).
5. The applicant demonstrates willingness to cooperate in a study
with CDC and other collaborating institutions. (10 points)
6. The size, qualifications, and time allocation of the proposed
staff and the availability of facilities are adequate for the study.
(10 points)
7. The budget is reasonable, clearly justified, consistent with the
intended use of funds, and allowable. All budget categories should be
itemized. (Not scored)
8. Procedures are adequate for the protection of human subjects,
whether
[[Page 37061]]
or not exempt from the Department of Health and Human Services (DHHS)
regulations. (Not scored) Recommendations on the adequacy of
protections include: (a) Protections appear adequate and there are no
comments to make or concerns to raise; (b) protections appear adequate,
but there are comments regarding the protocol; (c) protections appear
inadequate and the Objective Review Group (ORG) has concerns related to
human subjects; or (d) disapproval of the application is recommended
because the research risks are sufficiently serious and protection
against the risks are inadequate as to make the entire application
unacceptable.
Funding Priority
Priority will be given to competing continuation applications from
satisfactorily performing projects over applications for projects not
already receiving support under the program. Projects will be awarded
so that the composite of projects reflects the geographic and
demographic distribution of the study population.
Executive Order 12372 Review
Applications are not subject to review under Executive Order 12372,
Intergovernmental Review of Federal Programs.
Public Health System Reporting Requirements
This program is not subject to the Public Health System Reporting
Requirements.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance number is 93.944, Human
Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Virus Syndrome
(AIDS) Surveillance.
Other Requirements
1. Paperwork Reduction Act
Projects that involve the collection of information from 10 or more
individuals and funded by cooperative agreement will be subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act.
2. Human Subjects
This program involves research on human subjects. Therefore, all
applicants must comply with the Department of Health and Human Services
Regulations, 45 CFR part 46, regarding the protection of human
subjects. Assurance must be provided to demonstrate that the project or
activity will be subject to initial and continuing review by an
appropriate institutional review committee. The applicant will be
responsible for providing assurance in accordance with the appropriate
guidelines and form provided in the application kit.
In addition to other applicable committees, Indian Health Service
(IHS) institutional review committees also must review the project if
any component of IHS will be involved with or support the research. If
any American Indian community is involved, its tribal government must
also approve that portion of the project applicable to it.
3. HIV Program Review Panel
Recipients must comply with the document entitled Content of AIDS-
Related Written Materials, Pictorials, Audiovisuals, Questionnaires,
Survey Instruments, and Educational Sessions (June 1992) (a copy is in
the application kit). To meet the requirements for a program review
panel, recipients are encouraged to use an existing program review
panel, such as the one created by the State health department's HIV/
AIDS prevention program. If the recipient forms its own program review
panel, at least one member must be an employee (or a designated
representative) of a State or local health department. The names of the
review panel members must be listed on the Assurance of Compliance form
CDC 0.1113, which is also included in the application kit. The
recipient must submit the program review panel's report that indicates
all materials have been reviewed and approved.
4. Patient Care
Applicants should provide assurance that all HIV-infected patients
enrolled in their studies will be linked to an appropriate local HIV
care system that can address their specific needs such as medical care,
counseling, social services, and therapy. Details of the HIV care
system should be provided, describing how patients will be linked to
the system. Funds will not be made available to support the provision
of direct care for study participants.
5. Women, Racial and Ethnic Minorities
It is the policy of the CDC to ensure that individuals of both
sexes and the various racial and ethnic groups will be included in CDC-
supported research projects involving human subjects, whenever feasible
and appropriate. Racial and ethnic groups are those defined in OMB
Directive No. 15 and include American Indian, Alaskan Native, Asian,
Pacific Islander, Black and Hispanic. Applicants shall ensure that
women, racial and ethnic minority populations are appropriately
represented in applications for research involving human subjects.
Where clear and compelling rationale exist that inclusion is
inappropriate or not feasible, this situation must be explained as part
of the application. This policy does not apply to research studies when
the investigator cannot control the race, ethnicity and/or sex of
subjects. Further guidance to this policy is contained in the Federal
Register, Vol. 60, No. 179, Friday, September 15, 1995, pages 47947-
47951 (a copy is included in the application kit).
6. Confidentiality
Recipients must describe confidentiality and security provisions to
protect data collected through HIV/AIDS surveillance, including copies
of local data release policies; employee training in confidentiality
provisions; State laws, rules, or regulations pertaining to the
protection or release of surveillance information; and physical
security of hard copies and electronic files containing confidential
surveillance information. Recipients must describe any laws, rules,
regulations, or health department policies that require or permit the
release of patient identifying information collected under the HIV/AIDS
surveillance system to entities outside of the public health department
and measures the health department has taken to ensure that the
confidentiality of individuals reported to the surveillance system is
protected from further or unlawful disclosure.
Application Submission and Deadline
The original and two copies of the application PHS Form 5161-1 (OMB
Number 0937-0189) must be submitted to Van Malone, Grants Management
Officer, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry
Road, NE., Room 300, Mail Stop E-15, Atlanta, Georgia 30305 on or
before August 11, 1997.
1. Deadline
Applications shall be considered as meeting the deadline if they
are either:
A. Received on or before the stated deadline date; or
B. Sent on or before the deadline date and received in time for
submission to the independent review group. (Applicants must request a
legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or U.S. Postal Service. Private
metered postmarks shall
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not be accepted as proof of timely mailing.)
2. Late Applications
Applications that do not meet the criteria in 1.A. or 1.B. above
are considered late applications. Late applications will not be
considered in the current competition and will be returned to the
applicant.
Where To Obtain Additional Information
A complete program description, information on application
procedures, an application package, and business management technical
assistance may be obtained from Van Malone, Grants Management Officer,
Grants Management Branch, Procurement and Grants Office, Centers for
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,
Room 300, Mail Stop E-15, Atlanta, Georgia 30305, telephone (404) 842-
6575, Email address [email protected]. The announcement will be available on
one of two Internet sites on the publication date: CDC's home page at
http://www.cdc.gov, or at the Government Printing Office home page
(including free access to the Federal Register) at http://
www.access.gpo.gov.
Programmatic technical assistance may be obtained from Dr. Richard
Steketee or Dr. Marta Gwinn, Division of HIV/AIDS Prevention, National
Center for HIV, STD, TB Prevention, Centers for Disease Control and
Prevention (CDC), 1600 Clifton Road, NE., Mail Stop E-46, Atlanta,
Georgia 30333, telephone (404) 639-2090. Eligible applicants are
encouraged to call before developing and submitting their application.
Please refer to Announcement Number 797 when requesting information.
Potential applicants may obtain a copy of ``Healthy People 2000''
(Full Report: Stock No. 017-001-00474-0) or ``Healthy People 2000''
(Summary Report: Stock No. 017-001-00473-1) referenced in the
Introduction from the Superintendent of Documents, Government Printing
Office, Washington, DC 20402-9325, telephone (202) 512-1800.
Dated: July 3, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 97-18062 Filed 7-9-97; 8:45 am]
BILLING CODE 4163-18-P